Testicular cancer is the most common malignancy in men between 15 and 35 years of age. Seminoma is a type of germinal-cell tumor of the testes and accounts for half of the primary testicular tumors. Metastases are present in 10% of patients at initial presentation. Standard treatment for stage I seminoma, in which the tumor is confined to the testis and a lymphangiogram is negative, involves orchidectomy followed by ipsilateral irradiation of the para-aortic and pelvic lymph nodes. The treatment for Stage II seminoma, in which the tumor has spread to lymph nodes below the diaphragm, involves radiation treatment that extends to the involved anatomy.
About 10-20% of seminoma patients harbor micrometastases in the draining lymph nodes. Marks et al., J. Urol. 143:524 (1990). Therefore, the irradiation of regional lymph nodes as part of the standard treatment of Stage I seminoma is unnecessary in approximately 85% of all seminoma patients. Although post-orchidectomy radiation is generally well tolerated, local complications have been reported to include a higher incidence of second-site malignancies, impaired fertility, and persistent scrotal edema. Hunter, et al., Cancer 64:1608 (1989); Thomas, et al., J. Urol. 12:313 (1989).
These complications have led to the evaluation of post-orchidectomy surveillance without radiation as an alternative to management of stage I seminoma. Thomas, et al., supra (1989); Germalluch et al., Br. J. Urol. 73:172 (1994); Peckham et al., Br. J. Urol. 59:343 (1987). The instant invention is a response to the need for improved assays to detect the most common malignancy in adolescent and young adult men before it metastasizes and for detecting any recurrence of seminoma in seminoma patients.
In this context, therefore, a need exists for a highly sensitive and specific system for detecting the presence of seminoma that is safe and easy to manufacture and perform. Such a method would permit approximately 85% of all seminoma patients to avoid the complications associated with lymph node irradiation. In addition, a method that detects the presence of a seminoma may also be used to screen for residual seminoma or a relapse of the tumor.